US11883478B2ActiveUtilityA1

Method of treatment

40
Assignee: GLAXOSMITHKLINE BIOLOGICALS SAPriority: Mar 18, 2013Filed: Mar 17, 2014Granted: Jan 30, 2024
Est. expiryMar 18, 2033(~6.6 yrs left)· nominal 20-yr term from priority
Inventors:Yaela BaineJacqueline Miller
A61K 39/095A61K 39/102A61K 2039/55A61K 2039/6037A61K 2039/70Y02A50/30A61P 31/04
40
PatentIndex Score
0
Cited by
84
References
40
Claims

Abstract

The application discloses method of immunising against Neisseria meningitidis infection comprising the steps of a) immunising a human patient at a first age of between 0 and 11 months with a bacterial saccharide conjugate vaccine comprising at least one, two or three bacterial saccharide(s) separately conjugated to a carrier protein to form at least one, two or three bacterial saccharide conjugate(s); and b) immunising the human patient at a second age of between 12 and 24 months with a Neisseria meningitidis conjugate vaccine comprising at least two capsular saccharides selected from the group consisting of N. meningitidis serogroup A capsular saccharide (MenA), N. meningitidis serogroup C capsular saccharide (MenC), N. meningitidis serogroup W135 capsular saccharide (MenW135), and N. meningitidis serogroup Y capsular saccharide (MenY) conjugated separately to a carrier protein, wherein the Neisseria meningitidis conjugate vaccine is co-administered with a vaccine comprising diphtheria toxoid and tetanus toxoid.

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A method of immunising against  Neisseria meningitidis  infection, comprising the steps of:
 (a) immunising a human patient at a first age of between 0 and 6 months with a bacterial saccharide conjugate vaccine comprising bacterial saccharides each separately conjugated to tetanus toxoid carrier proteins, wherein the bacterial saccharides consist essentially of (i) a  N. meningitidis  serogroup C (MenC) capsular saccharide and a  Haemophilus  influenza (Hib) saccharide or (ii) a  N. meningitidis  serogroup C (MenC) capsular saccharide, a  N. meningitidis  serogroup Y (MenY) capsular saccharide and a  Haemophilus  influenza (Hib) saccharide, and wherein the tetanus toxoid carrier protein is present at a total TT content of 5-40 idg per dose; and 
 (b) immunising the human patient at a second age of between 13 and 20 months with a  Neisseria meningitidis  conjugate vaccine comprising  N. meningitidis  serogroup A capsular saccharide (MenA),  N. meningitidis  serogroup C capsular saccharide (MenC),  N. meningitidis  serogroup W135 capsular saccharide (MenW135), and  N. meningitidis  serogroup Y capsular saccharide (MenY) conjugated separately to a tetanus toxoid carrier protein which is present at a total dose of 30-80 μg, wherein the  Neisseria meningitidis  conjugate vaccine is co-administered with a vaccine comprising diphtheria, tetanus, and acellular pertussis antigens (DTPa), 
 wherein co-administration of the  Neisseria meningitidis  conjugate vaccine with the vaccine comprising DTPa in step b) results in an at least 10% increase in immunogenicity against at least one of MenA, MenC, MenW135, and MenY compared to where the  Neisseria meningitidis  conjugate vaccine is administered alone, measured by Serum Bacteriocidal Assay (SBA). 
 
     
     
       2. The method of  claim 1  wherein the immunisation of step a) involves the administration of 3 doses of the bacterial saccharide conjugate, optionally at 2, 4 and 6 months of age. 
     
     
       3. The method of  claim 1  wherein the vaccine comprising DTPa contains a hepatitis B antigen. 
     
     
       4. The method of  claim 1  wherein the vaccine comprising DTPa contains Inactivated Polio Virus (IPV). 
     
     
       5. The method of  claim 1  wherein step b) immunises the human patient at between 13 and 18 months of age. 
     
     
       6. The method of  claim 1  wherein step b) immunises the human patient at between 15-18 months of age. 
     
     
       7. The method according to  claim 1  wherein the  Neisseria meningitidis  conjugate vaccine of step b) contains  N. meningitidis  capsular saccharides having an average size of above 50 kDa. 
     
     
       8. The method according to  claim 1  wherein the  Neisseria meningitidis  conjugate vaccine of step b) contains  N. meningitidis  capsular saccharides each of which is either a native polysaccharide or is reduced in average size relative to a native polysaccharide by a factor of no more than 10 fold. 
     
     
       9. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains at least one  N. meningitidis  capsular saccharide which is a native polysaccharide. 
     
     
       10. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains at least one  N. meningitidis  capsular saccharide which is reduced in size by microfluidization. 
     
     
       11. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains at least one  N. meningitidis  capsular saccharide selected from the group consisting of MenY and MenW135 which are microfludized, optionally to reduce the average size no more than 10 fold relative to the native capsular polysaccharide. 
     
     
       12. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains at least one  N. meningitidis  capsular saccharide selected from the group consisting of MenA and MenC which is a native polysaccharide. 
     
     
       13. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains a MenA capsular saccharide having an average size of above 50 kDa. 
     
     
       14. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains a MenC capsular saccharide having an average size of above 50 kDa. 
     
     
       15. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains a MenY capsular saccharide, having an average size of above 50 kDa. 
     
     
       16. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains a MenW135 capsular saccharide having an average size of above 50 kDa. 
     
     
       17. The method according to  claim 1  wherein the  N. meningitidis  conjugate vaccine of step b) contains  N. meningitidis  capsular saccharide conjugates, each having a polysaccharide:carrier ratio of 1:5-5:1 or 1:1-1:4(w/w). 
     
     
       18. The method according to  claim 1  wherein at least one of the  N. meningitidis  capsular polysaccharides of the  N. meningitidis  conjugate vaccine of step (b) is directly conjugated to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b). 
     
     
       19. The method according to  claim 18  wherein the MenW135 and MenC and MenY capsular saccharides of the  N. meningitidis  conjugate vaccine of step (b) are directly conjugated to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b). 
     
     
       20. The method according to  claim 18  wherein the  N. meningitidis  conjugate vaccine of step b) contains at least one  N. meningitidis  capsular saccharide conjugate directly conjugated by 1-cyano-4-dimethylaminopyridinium tetrafluoroborate (CDAP) chemistry. 
     
     
       21. The method according to  claim 18  wherein the  N. meningitidis  conjugate vaccine of step b) contains conjugates wherein a ratio of MenW135 and/or MenY capsular saccharide to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b) is between 1:0.5 and 1:2. 
     
     
       22. The method according to  claim 18  wherein the  N. meningitidis  conjugate vaccine of step b) contains a MenC conjugate wherein the ratio of MenC polysaccharide to carrier protein is between 1:0.5 and 1:2. 
     
     
       23. The method according to  claim 18  wherein the  N. meningitidis  conjugate vaccine of step (b) contains one or more  N. meningitidis  capsular saccharide(s) conjugated via a linker to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b). 
     
     
       24. The method according to  claim 23  wherein the linker is bifunctional. 
     
     
       25. The method according to  claim 23  wherein the linker has two reactive amino groups. 
     
     
       26. The method according to  claim 23  wherein the linker has between 4 and 12 carbon atoms. 
     
     
       27. The method according to  claim 23  wherein the linker is adipic acid hydrazide (ADH). 
     
     
       28. The method according to  claim 23  wherein the  N. meningitidis  capsular saccharides is conjugated to the linker with CDAP chemistry. 
     
     
       29. The method according to  claim 23  wherein the carrier protein is conjugated to the linker using carbodiimide chemistry, optionally using 1-(3-Dimethylaminopropyl)-3-ethylcarbodiimide (EDAC). 
     
     
       30. The method according to  claim 23  wherein MenA comprises the one or more  N. meningitidis  capsular saccharide(s) conjugated via the linker to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b). 
     
     
       31. The method according to  claim 30  wherein the ratio of MenA polysaccharide to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b) is between 1:2 and 1:5. 
     
     
       32. The method according to  claim 23  wherein MenC comprises the one or more  N. meningitidis  capsular saccharide(s) conjugated via the linker to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b). 
     
     
       33. The method according to  claim 32  wherein the ratio of MenC polysaccharide to the tetanus toxoid carrier protein of the  N. meningitidis  conjugate vaccine of step (b) is between 1:2 and 1:5. 
     
     
       34. The method according to  claim 32  wherein the  N. meningitidis  conjugate vaccine of step b) further comprises a  H. influenzae  b capsular saccharide conjugated to a carrier protein. 
     
     
       35. The method according to  claim 32  wherein the  N. meningitidis  conjugate vaccine of step b) contains a  N. meningitidis  serogroup B antigen, a  N. meningitidis  serogroup B outer membrane vesicle preparation and/or a  N. meningitidis  serogroup B protein. 
     
     
       36. The method according to  claim 1 , wherein the  Neisseria meningitidis  conjugate vaccine of (b) does not comprise a  Haemophilus  influenza (Hib) saccharide conjugated to the tetanus toxoid carrier protein. 
     
     
       37. The method according to  claim 1 , wherein co-administration of the  Neisseria meningitidis  conjugate vaccine with the vaccine comprising DTPa in step (b) results in an at least 20% increase in immunogenicity against at least one of MenA, MenC, MenW135, and MenY compared to where the  Neisseria meningitidis  conjugate vaccine is administered alone, measured by Serum Bacteriocidal Assay (SBA). 
     
     
       38. The method according to  claim 1 , wherein co-administration of the  Neisseria meningitidis  conjugate vaccine with the vaccine comprising DTPa in step (b) results in an at least 30% increase in immunogenicity against at least one of MenA, MenC, MenW135, and MenY compared to where the  Neisseria meningitidis  conjugate vaccine is administered alone, measured by Serum Bacteriocidal Assay (SBA). 
     
     
       39. The method according to  claim 1 , wherein co-administration of the  Neisseria meningitidis  conjugate vaccine with the vaccine comprising DTPa in step (b) results in an at least 40% increase in immunogenicity against at least one of MenA, MenC, MenW135, and MenY compared to where the  Neisseria meningitidis  conjugate vaccine is administered alone, measured by Serum Bacteriocidal Assay (SBA). 
     
     
       40. A method of immunising against  Neisseria meningitidis  infection, comprising the steps of:
 (a) immunising a human patient at a first age of between 0 and 6 months with a bacterial saccharide conjugate vaccine comprising bacterial saccharides each separately conjugated to tetanus toxoid carrier proteins, wherein the bacterial saccharides consist essentially of (i) a  N. meningitidis  serogroup C (MenC) capsular saccharide and a  Haemophilus  influenza (Hib) saccharide or (ii) a  N. meningitidis  serogroup C (MenC) capsular saccharide, a  N. meningitidis  serogroup Y (MenY) capsular saccharide and a  Haemophilus  influenza (Hib) saccharide, wherein the tetanus toxoid carrier protein is present at a total TT content of 5-40 idg per dose, wherein the bacterial saccharide conjugate vaccine is co-administered with a first vaccine comprising diphtheria, tetanus, and acellular pertussis antigens (DTPa); and 
 (b) immunising the human patient at a second age of between 13 and 20 months with a  Neisseria meningitidis  conjugate vaccine comprising  N. meningitidis  serogroup A capsular saccharide (MenA),  N. meningitidis  serogroup C capsular saccharide (MenC),  N. meningitidis  serogroup W135 capsular saccharide (MenW135), and  N. meningitidis  serogroup Y capsular saccharide (MenY) conjugated separately to a tetanus toxoid carrier protein which is present at a total dose of 30-80 μg, wherein the  Neisseria meningitidis  conjugate vaccine is co-administered with a second vaccine comprising DTPa, 
 wherein co-administration of the  Neisseria meningitidis  conjugate vaccine with the vaccine comprising DTPa in step b) results in an at least 10% increase in immunogenicity against at least one of MenA, MenC, MenW135, and MenY compared to where the  Neisseria meningitidis  conjugate vaccine is administered alone, measured by Serum Bacteriocidal Assay (SBA).

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